Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

Kidney Transplant Clinical Trial

Official title:

Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182986
• Other study ID #: DAIT CTOTC-06
• Status: Completed
• Start date: August 14, 2014
• Est. completion date: May 15, 2019

Study information

• Verified date: August 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Solid organ transplantation is an important therapeutic option for children with a variety of end stage diseases. However, the same immunosuppressive medications that are required to prevent the child's immune system from attacking and rejecting the transplanted organ can predispose these individuals to developing a very serious cancer that is linked to Epstein-Barr virus (EBV).

Description:

EBV-associated post-transplant lymphoproliferative disease (PTLD) is the most common malignancy in children after transplant. Diagnosis and effective treatment of the EBV-associated cancer is hampered by our inability to determine which children are at risk of developing these cancers and to detect the cancer at an early stage. In this study, we plan to test new "biomarkers" in the blood of children that will tell us very early on if the child is at risk of developing the EBV-associated cancer or if the cancer is present. These studies provide new opportunities for detection, diagnosis, and treatment of children with EBV-associated, post-transplant cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 944
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Subject and/or parent or legal guardian must be able to understand and provide informed consent/assent;

• Candidate for or recipient of: heart, liver, heart with liver, small intestine, liver with small intestine, or kidney; and

• Subject enrolled within 3 years of transplant.

Exclusion Criteria:

• Previous diagnosis of PTLD;

• Transplant recipients of lung alone, or in combination with an eligible organ type;

• Pancreas transplantation with the exception of 'en bloc' transplant in combined liver and small intestine multivisceral transplantation;

• Any combination other than listed in inclusion criteria;

• History of any previous solid organ, stem cell, or bone marrow transplantation;

• Inability or unwillingness of the legal guardian and/or the subject to comply with the study protocol.

Related Conditions & MeSH terms

• EBV-Related PTLD
• Heart Transplant
• Kidney Transplant
• Liver Transplant
• Lymphoproliferative Disorders
• PTLDs
• Small Intestine Transplant

Intervention

Procedure:
• transplant
All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).

Drug:
• Immunosuppressive Drugs
Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami Health System	Miami	Florida
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Lucile Packard Children's Hospital Stanford	Stanford	California
United States	Medstar Georgetown Transplant Institute	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation in Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)	The development of EBV positive PTLD during the study period as assessed by the local site pathologist, with confirmation of the PTLD diagnosis by the Study Clinicopathological Review Board (SCPRB)	Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollment
Primary	Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1)	Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method	Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollment
Primary	Pathogenic Changes in B Cell Clonotype Development	Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)	Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment

External Links

•   Clinical Trials in Organ Transplantation in Children (CTOT-C)
•   National Institute of Allergy and Infectious Diseases (NIAID)